Associate Specialist - Premarket Regulatory Affairs

$70,000 - $80,000/Yr

Applied Medical Distribution - Rancho Santa Margarita, CA

Full-time - Entry Level

Rancho Santa Margarita, CA

Miscellaneous Manufacturing

About the position

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work full-time on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.

Responsibilities

• Contribute to regulatory strategy and submission.
• Participate in projects to maintain and improve the Quality Systems.
• Ensure that Applied Medical's Quality Systems conform to standards and regulations in regions where products are distributed.
• Engage in regulatory strategy planning and change management for various markets.
• Represent Regulatory Affairs in decision-making and interdepartmental meetings.
• Collaborate with Engineering, Clinical Development, and global regulatory teams.
• Generate, review, and approve regulatory documentation.
• Monitor the regulatory environment and keep current on relevant standards and regulations.
• Implement procedural updates and training to ensure conformance.
• Coordinate and respond to questions, acting as a liaison to internal and external customers.
• Participate in internal and external audits as required.
• Propose, initiate, and contribute to business process improvement projects.

Requirements

• At least one year of experience in Regulatory Affairs or Quality Assurance in the medical device industry.
• Proficient in interpreting regulations and standards.
• Highly motivated, self-starter, able to work independently and as part of a team.
• Strong analytical, detail-oriented, proactive mindset, not afraid to ask questions.
• Effective oral and written communication and presentation skills.
• Friendly, positive attitude, committed to excellent customer service.
• Exemplary time and resource management skills, able to multitask, organize, and prioritize.
• Strong technical writing skills.
• Committed to quality and continuous improvement, strives to meet or exceed customer expectations.

Nice-to-haves

• Bachelor's degree in Engineering, Physical or Biological Sciences, Regulatory, or other technical disciplines.
• Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices.
• Proficiency in speaking and writing in Japanese or Korean.

Benefits

• Competitive compensation range: $70000 - $80000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.